Design ownership and governance across Tier 1 capital projects ($50M+)
Provide process technology leadership with a focus on aseptic processing
Establish and maintain appropriate engineering design standards to ensure consistency across all CapEx projects
Develop and manage a knowledge management program to ensure all design content is available and understood globally and at site levels
Lead conceptual and detailed design phases for Tier 1 capital projects, ensuring compliance with cGMP, FDA, EMA, and global standards
Validate design deliverables against project scope, budget, and schedule
Develop initial project scope, basis of design, and feasibility assessments
Collaborate with stakeholders to define user requirements and design criteria
Execute design assurance reviews and health checks at key project milestones
Identify risks and implement corrective actions to maintain design integrity
Provide expert advice to site engineering teams on design standards and best practices
Mentor site engineers and promote knowledge sharing across global teams
Engage with external design partners and EPC firms to ensure quality and compliance
Drive sustainability and modular design strategies in capital projects
Serve as the global subject matter expert for aseptic processing technologies

Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Chemical, Civil, or related discipline)
12+ years in engineering design and process technology for GMP-regulated facilities, with at least 8 years in leadership roles
Proven track record in Tier 1 capital project design, assurance, and aseptic process technology leadership
PMP or equivalent; LEED or sustainability certification preferred
Strong knowledge of biopharma facility design, aseptic processing, clean utilities, HVAC, and process systems
Familiarity with ISPE Baseline Guides, ASTM E2500, and risk-based design approaches
Experience with biologics, cell & gene therapy, or sterile manufacturing facilities
Proficiency in BIM, AutoCAD, and digital design platforms

Design & Technology Lead

Key skills